FDA USE OF EUROPEAN CE MARK TO STREAMLINE DEVICE REVIEW PROCESS UNDER DISCUSSION; AGENCY STAFFERS SOUND REGULATORY REFORM THEME AT FDLI MEETING
This article was originally published in The Gray Sheet
Executive Summary
FDA is exploring use of the CE mark of product approval in Europe to replace scientific data requirements in the device review process, Philip Phillips, deputy director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health, said Dec. 13 at the Food and Drug Law Institute's annual education conference in Washington, D.C.